Job Summary:

My client is a well-established Pharmaceutical organization developing, manufacturing and selling prescription and OTC drugs on a global basis. I am recruiting for a Senior Compliance Auditor to hold responsible for conducting internal and external audits for the GCP / GLP activities


Description of Duties:

Independently schedules and conducts external domestic and foreign field audit activities including clinical
investigators, CROs, computer systems and clinical / non-clinical facilities. Conducts internal audit activities
including review of study reports, study protocols, informed consents etc. Participates in system audits of processes
and procedures. Provides GCP / GLP compliance representation to clinical teams. Provides input into the
development of department SOPs. Presents GCP Compliance perspectives at investigator meetings and other
internal functions. Participates in the training of new employees.

Position Requirements:

- B.S. in the Life Sciences.

- Minimum of 5+ years related pharmaceutical industry experience preferably in Clinical Quality Assurance,
clinical research or field monitoring.

- Excellent knowledge of FDA, GCP, GLP and ICH guidelines/regulations.

- Experience in computer validation compliance highly desirable. Previous GCP / GLP auditing experience is
preferred.

- A second language is a desirable asset.

- Excellent medical/scientific written and verbal communication skills.

- Good computer skills in MS Word, Outlook, Excel and Powerpoint.

- Approximately 25% travel is required.

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